Empirical EUA Statement
The QuantiTASE Plus One Step RT-qPCR SARs-CoV-2 assay kit is available for In Vitro Diagnostic (IVD) use in accordance with the May 11 2020 FDA guidance document titled: Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
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The QuantiTASE PLUS kit is a high performance version of the Empirical Bioscience QuantiTASE RT-qPCR Universal Kit. The kit contains an aptamer modified warm start version of Empirical RTScript (M-MLV) Reverse Transcriptase Enzyme mix, InhibiTaq PLUS Hotstart qPCR Mastermix, inter-calculating dye and supplemental ROX reference dye.
InhibiTaq PLUS qPCR Mastermix is a proprietary mix containing a proprietary chemically modified Hot Start (2 minute Activation) Taq polymerase and novel buffer system which has been developed to tolerate inhibitors commonly found in many samples. It is designed to reduce the amount of sample processing required for reliable qPCR analysis and can be used for amplification from inhibitor-rich samples such as urine, saliva, cerebral spinal fluid (CSF), whole blood, serum, plasma, feces and plants samples.
The Mastermix also contains dUTP and UDG, allowing the end-user to minimize carryover contamination, providing high performance on samples from diverse sources and of different target types. The qPCR Mastermix contains a passive ROX reference dye enabling use on a wide variety of instruments. This means that on most platforms no additional components are required to ensure compatibility. A supplemental ROX solution is also included for use, should it be required. The enzymes and buffer system has been optimized to support both One Step and Two Step RT-qPCR protocols.